Pilot Testing ADAPT a Bereavement Care Intervention

NCT04929405 | Completed

• 1 other identifier: UMCIRB 19-001984
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Parental bereavement experiences are unique and require interventions adaptable to individual experiences.The web-based, multi-modal intervention, labeled ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). A quasi-experimental, treatment-only design will be used for this study. The hypothesis is that the ADAPT intervention will promote positive adaptation to influence grief integration and consequently affect health outcomes (improved sleep and social interactions, and decreased anxiety and depressive symptoms).The purpose of this study is to describe the nature and degree of clinical benefit of the intervention on bereaved parents' health outcomes.

Conditions

Bereavement

Keywords

Bereavement; Palliative Care; Web-based Intervention

Outcome Measures

Primary Outcomes (2)

• Recruitment

  Recruited 35 participants in the study timeframe

  3 months

• Retention

  Participants complete surveys at pre and post intervention.

  3 months

Secondary Outcomes (5)

• Sleep

  3 months

• Grief

  3 months

• Social isolation

  3 months

• Anxiety

  3 months

• Depression

  3 months

Study Arms (1)

Intervention group

EXPERIMENTAL

This group has access to the intervention (website for bereaved parents)

Behavioral: ADAPT

Interventions

ADAPT BEHAVIORAL

ADAPT, is multi-modal to promote a targeted approach to individual parental bereavement experiences and is not time or geographically limited. ADAPT is based on the theoretical foundations of the Adaptive Leadership (AL) framework. Our interdisciplinary team developed a web-based, multi-modal intervention, labeled ADAPT, that incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). Parents can download ADAPT on any digital device (phones/computers) using a Quick Response (QR) bar code or weblink.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological parent and legal guardian of a deceased child who was 18 years old or younger at time of death
• Cause of death of the deceased child is illness
• Parent age 18 years or older at time of child's death
• Ability to speak and read English sufficient to participate in the study

You may not qualify if:

• Step-, foster-, grand- or fictive parent of a child who has died
• Deceased child was unborn or over age 18 years at time of death
• Deceased child was in legal custody of county or state jurisdiction
• Cause of child's death was in utero or traumatic
• Parent age less than 18 years
• Inability to speak and read English sufficient to participate

Sponsors & Collaborators

• East Carolina University: lead
• Palliative Care Research Cooperative Group: collaborator
• Akron Children's Hospital: collaborator

Study Sites (2)

Cardinal Glennon Childrens Hospital

St Louis, Missouri, 63104, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Study Officials

• Nancy Dias, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: June 18, 2021
• Study Start: March 3, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)